Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Results 'read across' from study on TDA, propxylated, as permitted by Annex XI para 1.5, based on the justification in the report by Paul Illing Consultancy Services Ltd and Marlin Consultancy (Illing and Barratt, 2010). Thus, on animal welfare grounds this test should not be undertaken on TDA, ethoxylated and propoxylated. For further details concerning the grouping, consult Illing and Barratt, 2010.

A reproduction toxicity screening study (oral gavage) with Diaminotoluene, propoxylated following the OECD guideline 421 is available for the endpoint. No substance related impairment or adverse effects on reproduction were observed at any dose levels examined including 160 mg/kg bw/day.

Diaminotoluene, propoxylated is not classifiable as hazardous in respect to its reproductive toxicity. There is sufficient information from a qualitative and quantitative understanding of the toxicological properties of the core substance, the repeating unit, and screening studies on the most bioavailable members of the category, such that testing for reproductive toxicity is not necessary. In view of this, no further testing is proposed (see also Illing & Barratt, 2007).


Short description of key information:
NOAEL (reproductive toxicity): ≥ 160 mg/kg bw.

Effects on developmental toxicity

Additional information

Results 'read across' from study on TDA, propxylated, as permitted by Annex XI para 1.5, based on the justification in the report by Paul Illing Consultancy Services Ltd and Marlin Consultancy (Illing and Barratt, 2010). Thus, on animal welfare grounds this test should not be undertaken on TDA, ethoxylated and propoxylated. For further details concerning the grouping, consult Illing and Barratt, 2010.

Diaminotoluene, propoxylated and ethoxylated is not classifiable as hazardous in respect to its reproductive toxicity. There is sufficient information from a qualitative and quantitative understanding of the toxicological properties of the core substance, the repeating unit, and screening studies on the most bioavailable members of the category, such that testing for developmental toxicity is not necessary. In view of this, no further testing is proposed (see also Illing & Barratt, 2007).

Justification for classification or non-classification

The findings in the available study do not warrant classification according to the EU criteria.